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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Generic Sirona Kit
DATRIX LLC
RX93051-000
Not in Commercial Distribution

  • 00851074007088 ()


  • Telemetric electrocardiographic ambulatory recorder
ECG Recorder
DATRIX LLC
RX93030-000
In Commercial Distribution

  • 00851074007002 ()


  • Telemetric electrocardiographic ambulatory recorder
Visix software for use with just an intraoral camera version 2.3.10
TELEVERE SYSTEMS, LLC
for Intraoral Camera 2.3.10
In Commercial Distribution

  • 00851800007092 ()
Visix for Intraoral Camera 2.3.10

  • Camera application software
  • Radiological PACS software
Communication Gateway Server CGS-9001 (Pager Commnunication Gateway Server)
Nihon Kohden Digital Health Solutions, LLC
CGS-9001
In Commercial Distribution

  • 00851725007092 ()
CGS-9001

  • Medical networking interface unit
External Patient Activator
ST. JUDE MEDICAL, INC.
DM2100A
In Commercial Distribution

  • 05414734502696 ()
DM2100A

  • Implantable cardiac monitor programmer/transmitter/alarm
Wireless Adapter
Thoratec Corporation
HMT2100
In Commercial Distribution

  • 05415067032065 ()
HMT2100

  • Medical networking interface unit
Mobile Application
ST. JUDE MEDICAL, INC.
APP1001
In Commercial Distribution

  • 05415067027405 ()
APP1001

  • Implantable cardiac monitor programmer/transmitter/alarm
Mobile Application
ST. JUDE MEDICAL, INC.
APP1000
In Commercial Distribution

  • 05415067027399 ()
APP1000

  • Implantable cardiac monitor programmer/transmitter/alarm
PW USB Receiver
ST. JUDE MEDICAL, INC.
PW USB Receiver
In Commercial Distribution

  • 05415067023384 ()
C12781

  • Medical networking interface unit
AO USB Receiver
ST. JUDE MEDICAL, INC.
AO USB Receiver
In Commercial Distribution

  • 05415067023377 ()
C12782

  • Medical networking interface unit
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